Outcomes of the Nanoscopic Partial Meniscectomy Versus Standard Arthroscopic Partial Meniscectomy

Standard arthroscopy has been the gold standard for treatment of meniscus tears since the 1980's. The purpose of this study is to analyze the clinical outcomes of using the smaller diameter Nanoscope for partial menisectomy. The authors hypothesize that the Nanoscopic partial menisectomy patients will have less pain and return function faster than standard arthroscopy.

Study Overview

• Status: Recruiting
• Conditions: Meniscus Tear
• Intervention / Treatment: Procedure: Nanoscopic partial meniscectomy; Procedure: Standard Partial Meniscectomy

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shane Taylor; Phone Number: 6094729212; Email: taylorsh@marshall.edu
• Study Contact Backup: Name: Chad Lavender; Phone Number: 3045526514; Email: doclav@gmail.com

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Active, not recruiting
      • MedStar Washington Hospital Center
  • West Virginia
    • Scott Depot, West Virginia, United States, 25560
      • Recruiting
      • Marshall Orthopaedics - Teays Valley
      • Contact: Chad Lavender; Phone Number: 304-552-6514; Email: doclav@gmail.com
      • Principal Investigator: Chad Lavender, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• MRI positive for meniscus tear
• More than 3mm of joint space on PA flexion weightbearing x rays
• Primary arthroscopy

Exclusion Criteria:

• Workers compensation
• Older than 60 years of age
• Revision surgeries

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nanoscopic Partial Meniscectomy; This is the experimental group. patients will have a partial meniscectomy performed using the arthrex nanoscope	Procedure: Nanoscopic partial meniscectomy; Patients will have a partial meniscectomy performed using the arthrex nanoscope and it will be compared to partial meniscectomy performed using standard arthroscopic equipment
Active Comparator: Standard Partial Meniscectomy; Patients will have a partial meniscectomy performed using standard arthroscopic equipment which is the current gold standard	Procedure: Standard Partial Meniscectomy; Patients will have partial meniscectomy performed using standard arthroscopic equipment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Outcomes following partial meniscectomy: Knee Injury and Osteoarthritis Score	We will be looking at functional outcomes following partial meniscectomy with the nanoscope compared to standard arthroscopy by looking at Knee Injury and Osteoarthritis Score (O -100 with higher being patients doing better functionally)	6 weeks
Functional Outcomes Following Partial Meniscectomy: International Knee Documentation Committee Score	We will be looking at functional outcomes following partial meniscectomy with the nanoscope compared to standard arthroscopy by looking at the International Knee Documentation Committee Score (0-100 with higher being patients doing better functionally)	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain: Visual Analog Pain Score	Pain following partial meniscectomy with the nanoscope compared to standard arthroscopy using Visual Analog Pain Score (0-10 with 0 being no pain and 10 being the worst pain)	6 weeks
Narcotic Medication Use	we will be looking at the amount of narcotic pain medication used following nanoscopic partial meniscectomy compared to standard arthroscopy	24 hours
Return to work	time to return to work following partial meniscectomy	6 weeks

Collaborators and Investigators

• Sponsor: Marshall University
• Collaborators: Arthrex, Inc.; Medstar Washington Hospital Center

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: November 12, 2022
• First Posted (Actual): November 16, 2022

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Arthroscopy; Meniscectomy; Meniscus; Nanoscopic
• Other Study ID Numbers: 1926751-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes